The Effect of Portable AR on Tooth Brushing Skill for Elementary School Students

Healthy Clinical Trial

Official title:

The Effect of Portable AR on Tooth Brushing Skill for Elementary School Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05956262
• Other study ID #: KMUHIRB-SV(I)-20200073
• Status: Completed
• Phase: N/A
• Start date: November 25, 2021
• Est. completion date: May 20, 2022

Study information

• Verified date: November 2021
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study An augmented reality (AR) simulation toothbrushing machine was developed to train proper brushing technique for children. The investigators aimed to evaluate the effects of AR brushing machine on knowledge of dental clearing skill, self-efficacy and dental plaque control in elementary schoolchildren in Taiwan.

Description:

A quasi-experimental design was conducted; ten intervention schools (AR group) and ten comparison schools were selected from elementary schools. Overall, grade 3-6 students in the AR group (n = 290) and the traditional group (n = 311), respectively. Students in the AR group received a two-time repeated AR-based training for 30 minutes at two-week intervals. Students in the CG received traditional classroom-based teaching. Baseline and follow-ups information was collected using dental plaque examinations and questionnaires. The generalized estimating equations(GEE) were used to evaluate the outcomes between two groups over time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

Inclusion Criteria:

• Primary school students 3 to 6 grades

Exclusion Criteria:

• Schoolchildren with disability certification.

• Schoolchildren with congenital severe oral diseases (eg. cleft lip and palate )

• Disability to operate the AR system

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• AR-toothbrush machine
Student in AR group received a two-time repeated AR-based training for 30 minutes at two-week intervals. The AR-based training system (PVIX Oral, EPED) digitized the steps of the toothbrushing technique applying optical tracking technology to enable the participants to obtain immediate scoring after the completion of practice. The scoring depends on the level of removing simulated dental plaque. The AR system was equipped with an optical tracking unit, a 3D training head model, and a wireless toothbrush. The toothbrushing practice time for the upper and lower jaw is 3 minutes, respectively. A tooth-brushing song played while the students implemented.

Behavioral:
• Teach proper brushing skills
Students in the traditional group received a two-time repeated 10-minute lesson regarding proper toothbrushing skills in the classroom at two-week intervals. The students were taught by a well-trained dental hygienist using teaching aids (such as dental models, and toothbrushes).

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	National Sun Yat-sen University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Control Record (PCR)	Each tooth is divided into six surfaces, and the PCR record is calculated ( range 0-100% )	Change from Baseline at 2-week after intervention
Primary	Plaque Control Record (PCR)	Each tooth is divided into six surfaces, and the PCR record is calculated ( range 0-100% )	Change from Baseline at 4-week after intervention
Primary	Self-efficacy	2 questions , e.g: I feel confident.Response 1 = strongly disagree 2 = Disagree 3 = Normal 4 = agree 5 = strongly agree	Change from Baseline at 2-week after intervention
Primary	Self-efficacy	2 questions , e.g: I feel confident.Response 1 = strongly disagree 2 = Disagree 3 = Normal 4 = agree 5 = strongly agree	Change from Baseline at 4-week after intervention
Primary	Skill of Toothbrushing	5 questions , e.g: The toothbrush is pressed against the gums at a 45-degree angle.Response multiple choice	Change from Baseline at 2-week after intervention
Primary	Skill of Toothbrushing	5 questions , e.g: The toothbrush is pressed against the gums at a 45-degree angle.Response multiple choice	Change from Baseline at 4-week after intervention